Sodium Valproate-loaded Nanospanlastics in Patchy Alopecia Areata in Comparison to Topical Steroids

Alopecia Areata Clinical Trial

Official title:

Assessment of Efficacy and Safety of Sodium Valproate -Loaded Nanospanlastics in Patients With Patchy Alopecia Areata in Comparison to Conventional Therapy With Topical Steroids: a Randomized Controlled Study, With Clinical, Dermoscopic and Molecular Asessements

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05017454
• Other study ID #: 264199200
• Status: Completed
• Phase: Early Phase 1
• Start date: May 1, 2021
• Est. completion date: April 1, 2023

Study information

• Verified date: June 2023
• Source: Kasr El Aini Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

the aim of this study is to assess the efficacy and safety of sodium valproate-loaded nanospanlastic in the treatment of patchy AA, in comparison to conventional therapy with topical steroids

Description:

Alpopecia Areata (AA) is the second common cause of non-scarring hair loss, the disease has huge negative impact on patients' quality of life, social and psychological status. The underlying pathogenesis of AA is not fully characterized, Yet the collapse of immune privilege and generation of autoimmune attack against unknown follicular antigens are the most agreed-upon theories behind the disease. In spite of various therapeutic armamentariums available for AA, no single agent has been proven efficacious regarding reversing hair loss and establishing long-term response.

keeping in mind the burden of the disease together with lacking effective treatments, a need for further therapies is colossal.

Wnt-b catenin pathway is one of the crucial signalling pathways that regulate hair cycling. An increasing body of evidence is supporting the fact that wnt-b catenin pathway is inhibited in AA, and therefore contributing to the hair loss that characteize the disease.

Sodium valproate (SV), a well-known anti-epileptic drug, was found to inhibit Glycogen synthase kinase-3beta (GSK3β) in neuronal cells as one of the possible antiepileptic mechanisms of SV. GSK3B is a well-known inhibitor of β-catenin activity in dermal papilla cells (DPCs), and thus induces catagen-like changes in these cells. So the idea of using topical SV to promote hair regrowth via activation of b catenin came up and attracted the interests of investigators. recently an optimized sodium valproate-loaded nanospanlastics topical formula promisingly achieved clinical equivalence with 5% minoxidil lotion in AGA, with a superior safety profile to minoxidil

Recruitment information / eligibility

• Status: Completed
• Enrollment: 67
• Est. completion date: April 1, 2023
• Est. primary completion date: January 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years and older

Eligibility

Inclusion Criteria:

• Patients with mild to moderate patchy alopecia areata, which is defined as less than 50% involvement of the entire scalp

• Age above 12 years.

• Both genders.

• Patients with patchy alopecia areata, with 2 patches or more

Exclusion Criteria:

• Patients having single patch alopecia areata (at least 2 patches are required, as one patch will be left untreated to exclude the possibility of spontaneous remission)

• Affection of more than 50% of the scalp area

• Patients with alopecia totalis or universalis

• Patients with ophiasis

• Age: Less than 12 years old.

• Pregnant or lactating females

• Patients with history of or existing scalp skin diseases, infections or skin cancer

• Severe systemic illness (as uncontrolled DM or hypertension, liver or renal diseases) and immune-compromised patients

• Patients with concomitant autoimmune diseases as suspected by history or confirmed by previous investigations

• Diagnosis or history of local dermatological disease in the scalp apart from AA such as eczema, seborrheic dermatitis, psoriasis.

• Any psychiatric illness or psychological state impairing future compliance or influencing expectations of the patient

Related Conditions & MeSH terms

• Alopecia
• Alopecia Areata

Intervention

Drug:
• the optimized sodium valproate-loaded nanospanlastic dispersion
participants will apply the optimized sodium valproate-loaded nanospanlastic dispersion twice daily, on the affected areas of the scalp for 3 months
• mometasone furoate lotion
participants will apply marketed mometasone furoate lotion twice daily on the affected areas of the scalp for 3 months

Locations

Country	Name	City	State
Egypt	Kasralainy Hospital, Dermatology Department	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Kasr El Aini Hospital

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	- Treatment success	defined by achieving = 50% reduction in baseline SALT score at end-of-study and/or achieving patient global assessment of improvement (PGAI) = 50%.	6 months
Secondary	molecular Assessment of treatment success rate of SV-loaded nanospanlastics in the treatment of mild to moderate patchy AA in comparison to conventional therapy with topical steroids	Assessment of expression of both beta-catenin and Axin2 in lesional scalp of patients with patchy AA before and after treatment with sodium valproate-loaded nanospanlastics, in comparison to conventional therapy with topical steroids	3 months
Secondary	Dermoscopic evaluation of hair regrowth	This evaluation will determine the number of dystrophic hairs in the patch area at baseline to be compared after the end of treatment. Markers for dystrophic hairs include exclamation-mark hairs, black dots, yellow dots and pigtail regrowing hair. The percentage of dystrophic hairs will be evaluated on a four-point scale: 3, > 50%; 2, 30-50%; 1, 1-29%; 0, no dystrophic hairs	3 months
Secondary	Patient global assessment of improvement	Patient global assessment of improvement will be evaluated at the end of study, and will be scored as the following; (0 =no regrowth; 1 = <25% of regrowth; 2 = 25%-49% of regrowth; 3 = 50%-74% of regrowth; 4 = 75%-99% of re- growth; 5 = 100% of regrowth)	3 months
Secondary	Clinical satisfaction of each patient	Clinical satisfaction of each patient will be made using a 10-point visual analogue scale (VAS, 0-10; the 0 level was defined as "Not satisfied at all," while a level of 10 was defined as "completely satisfied")	3 months
Secondary	Subjective assessment of any encountered adverse effects	Subjective assessment of any encountered adverse effects (burning, itching) will also be performed. This will be determined on a four-point scale: 3, strong sensation; 2, moderate sensation; 1, mild sensation; 0, no itching or burning sensation	3 months
Secondary	Patient satisfaction regarding characteristics of the used topical treatment	Patient satisfaction regarding characteristics of the used topical treatment, for example (texture, spreadability, hair matting, odour). This will be evaluated on a 3-point scale; 0=unsatisfied, 1=moderately satisfied, 2=extremely satisfied	3 months
Secondary	Dermatology Life Quality Index (DLQI)	Dermatology Life Quality Index (DLQI) will be evaluated at baseline and at the end of therapy, using a validated DLQI questionaire	3 months
Secondary	Assessment of relapse	Patients who achieved 100% reduction in baseline SALT after 3 months of treatment (end of therapy) were followed up for additional 3 months (end of study) to monitor any relapses.	6 months